Multisensory and cognitive support to aid recovery after heart surgery
Effects of Multisensory and Cognitive Interventions Applied in the Intensive Care Unit on Physiological, Psychological and Functional Outcomes
NA · Abant Izzet Baysal University · NCT07116941
This trial will test whether 30-minute sensory (music, scent, touch) or thinking exercises during early ICU mobilization help adults after cardiac surgery feel less anxious and regain physical independence faster.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Abant Izzet Baysal University (other) |
| Locations | 1 site (Bolu) |
| Trial ID | NCT07116941 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial enrolls adults 18–80 who are hemodynamically stable after CABG or other open-heart surgery and ready for early mobilization in the ICU. Participants are randomly assigned to one of four 30-minute interventions during the sitting phase: standard care, cognitive stimulation, auditory stimulation (music or nature sounds), or multisensory stimulation (lavender or mint aroma combined with tactile hand therapy). The primary outcome is change in functional independence measured by the Functional Independence Measure (FIM), with secondary outcomes including heart rate, blood pressure, oxygen saturation, and self-reported anxiety (VAS). The study compares physiological, psychological, and functional recovery immediately after the intervention and during early rehabilitation.
Who should consider this trial
Good fit: Adults aged 18–80 who have undergone CABG or other open-heart surgery, are hemodynamically stable, alert, able to communicate, and eligible for early mobilization in the ICU.
Not a fit: Patients with ICU delirium or altered mental status, severe hemodynamic instability, significant cognitive or sensory deficits, or known sensitivity/allergy to auditory or olfactory stimuli are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, these low-risk interventions could reduce anxiety, improve hemodynamic stability, and speed recovery of physical independence after cardiac surgery.
How similar studies have performed: Previous studies have reported benefits from music, aromatherapy, tactile stimulation, and cognitive exercises individually, but comparative or combined multisensory approaches in the ICU remain largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 80 years * Underwent coronary artery bypass grafting (CABG) or other open-heart surgery * Admitted to the ICU postoperatively and eligible for early mobilization * Hemodynamically stable (within normal blood pressure and heart rate ranges, without inotropic support) * Alert and able to communicate Exclusion Criteria: * Diagnosis of ICU delirium or altered mental status * Severe hemodynamic instability * Presence of neurological disease or significant cognitive impairment * Significant sensory deficits (e.g., severe hearing or vision loss) * Known allergy or psychological sensitivity to auditory or olfactory stimuli (e.g., aromatherapy or music)
Where this trial is running
Bolu
- Bolu Abant Izzet Baysal University, Izzet Baysal Training and Research Hospital — Bolu, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Alp Ozel, PT, PhD — Abant Izzet Baysal University
- Study coordinator: Alp Ozel, PT, PhD
- Email: alpozel@ibu.edu.tr
- Phone: +903742534520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Bypass Graft, Cardiac Surgery Subjects, Postoperative Care, Early Mobilization, Intensive Care Unit, Cardiac Surgery, Multisensory Intervention, Anxiety